The study involves annual 4D CTA imaging of the bicuspid aortic valve for a period of 5 years. CTA is often standard of care for BAV patients, but patients in this study will receive a higher radiation dose with a 4D imaging protocol. There may also be patients enrolled in the study who have a 4D CTA for research purposes when a routine CTA is not required for clinical care.
The bicuspid aortic valve (BAV) is the most common congenital heart disease. The purpose of this study is to better understand the anatomy of physiologically normal, or competent, BAVs without stenosis or insufficiency (AI) in order to support evidence-based standardization of BAV repair surgery. Men and women over 18 years of age with a diagnosis of BAV and minimal aortic valve calcification at baseline will undergo annual 4D computed tomography angiography (CTA) scans, routine transthoracic echocardiograms, and history and physical assessments over the course of the 5-year study period. Patients who are pregnant, have renal insufficiency (creatinine 2 mg/dL), or who have a contraindication to intravenous contrast will be excluded. Patients will be stratified into study groups according to baseline AI: approximately half of patients will have no to mild AI at baseline and the other half will have moderate to severe AI at baseline. Anatomical measurements will be obtained from the 4D CTA scans and analyzed at each phase of the cardiac cycle, as well as longitudinally. The 4D CTA imaging and analysis will not impact medical care of the study participants; the anatomical measurements will be used in the future as evidence-based standards for determining valve repair candidacy for BAV patients with AI.
Study Type
OBSERVATIONAL
Enrollment
60
4D CTA imaging
University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGCusp surface areas over the cardiac cycle
Surface area of each cusp in mm2 in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.
Time frame: Through study completion, an average of 1 year
Cusp height (geometric and effective)
Geometric and effective cusp height in mm in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.
Time frame: Through study completion, an average of 1 year
Cusp free margin length
Length of the free margin of each cusp in mm in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.
Time frame: Through study completion, an average of 1 year
Cusp thickness (including raphe thickness, if applicable)
Thickness of each cusp in mm in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.
Time frame: Through study completion, an average of 1 year
Commissural height
Height of each commissure in mm in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.
Time frame: Through study completion, an average of 1 year
Sino tubular junction size
Diameter of the sinotubular junction in mm in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.
Time frame: Through study completion, an average of 1 year
Size of the sinuses of Valsalva
Maximum diameter of the sinuses of Valsalva (mid-level of the aortic root) in mm in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.
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Time frame: Through study completion, an average of 1 year
Ventriculoaortic junction size
Diameter of the ventriculoaortic junction in mm in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.
Time frame: Through study completion, an average of 1 year
Aortic annulus size
Diameter of the aortic cusp in mm measured in one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.
Time frame: Through study completion, an average of 1 year
Coaptation height at diastole
Length of the coaptation zone of the cusps in mm when the valve is closed. This measurement is made in one cardiac cycle (\~0.6 - 1s in length) from the CT image.
Time frame: Through study completion, an average of 1 year
Cusp displacement over the cardiac cycle
Total displacement of the center of the free margin of each cusp in mm during one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.
Time frame: Through study completion, an average of 1 year
Cusp velocity over the cardiac cycle
Maximum velocity of the center of the free margin of each cusp in mm/s during one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.
Time frame: Through study completion, an average of 1 year
Size of the ascending aorta
Maximum diameter of the ascending aorta in cm during one cardiac cycle (\~0.6 - 1s in length). This measurement is made directly from the CT image.
Time frame: Through study completion, an average of 1 year
Development of aortic insufficiency and/or stenosis.
Degree of aortic insufficiency as measured on standard-of-care echocardiography
Time frame: Through study completion, an average of 1 year
Development of aortic insufficiency and/or stenosis.
The need for surgical intervention for disease of the aortic valve and/or ascending aorta
Time frame: Through study completion, an average of 1 year